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Effectiveness of patient self-managed structured education for type 2 diabetes (The Diabetes Manual): a cluster randomised-controlled trial

Effectiveness of patient self-managed structured education for type 2 diabetes (The Diabetes Manual): a cluster randomised-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN06315411
Enrollment
424
Registered
2006-01-20
Start date
2004-06-08
Completion date
Unknown
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes

Interventions

The Diabetes Manual Programme is administered to participants in the intervention group and compared to patients in the delayed intervention group who receive the intervention six months later.

Sponsors

University of Warwick (UK) - Centre for Primary Health Care Studies
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Less than 18 years 2. Confirmed clinical diagnosis of type 2 diabetes 3. Last clinical HbA1c not less than 7.0% 4. Ability to use the materials

Exclusion criteria

Exclusion criteria: 1. People taking insulin 2. People with learning disabilities and dementia 3. People whose health care needs are met by others (e.g. carers/nurses) 4. Unable to attend the surgery

Design outcomes

Primary

MeasureTime frame
HbA1c. Follow up for all measures is at six months post randomisation for both arms and 12 months post randomisation for the intervention arm to assess maintenance of effect on all measures.

Secondary

MeasureTime frame
1. Cholesterol 2. High Density Lipoprotein (HDL) cholesterol 3. Blood Pressure (BP) 4. Height, weight and Body Mass Index (BMI) calculated 5. Psychological distress, measured using a self-completion patient postal questionnaire 6. Quality of life 7. Self-efficacy Follow up for all measures is at six months post randomisation for both arms and 12 months post randomisation for the intervention arm to assess maintenance of effect on all measures.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026